Impact of obesity on underreporting of energy intake in type 2 diabetic patients: Clinical Evaluation of Energy Requirements in Patients with Diabetes Mellitus (CLEVER-DM) study.

BACKGROUND & AIMS: Although accurate assessment of energy intake (EI) is critical in diabetes care, underreporting of EI on dietary records (DR) is often an issue. However, few studies have examined EI with doubly labeled water (DLW) in patients with diabetes mellitus. We aimed to investigate the impact of sex and obesity on the dissociation of DR from total energy expenditure (TEE) evaluated with DLW in patients with type 2 diabetes. METHODS: Fifty-two patients with type 2 diabetes aged 60-79 years were enrolled for the Clinical Evaluation of Energy Requirements in Patients with Diabetes Mellitus (CLEVER-DM) study at a single university hospital. TEE was measured over 14 days by the DLW method as standard. EI was calculated by assessment of 3-day DR by registered dietitians. RESULTS: The mean difference between EI and TEE was 238 ± 412 kcal/day (~10% of TEE). Neither EI nor TEE was significantly different between obese (body mass index (BMI) ≥25 kg/m2) and non-obese (BMI <25 kg/m2) patients. There was a negative correlation between EI/TEE ratio and BMI in women (R = -0.437, P = 0.033) but not in men (R = -0.174, P = 0.377). There was a significant difference in EI/TEE ratio between obese and non-obese patients among women (0.85 ± 0.15 vs. 1.01 ± 0.21, P = 0.045) but not men (0.85 ± 0.20 vs. 0.87 ± 0.17, P = 0.79). CONCLUSIONS: EI calculated by 3-day DR may underestimate habitual intake, which is assumed to be equal to TEE measured by the DLW method except in non-obese women with diabetes. CLINICAL TRIAL REGISTRATION NUMBER: UMIN000023051.

Liver fat accumulation assessed by computed tomography is an independent risk factor for diabetes mellitus in a population-based study: SESSA (Shiga Epidemiological Study of Subclinical Atherosclerosis).

AIMS: Ectopic fat accumulation is related to insulin resistance and diabetes mellitus (DM). However, the effect of fatty liver on DM in non-obese individuals has not been clarified. We investigated whether liver fat accumulation assessed by computed tomography (CT) is associated with the incidence of DM. METHODS: In a prospective population-based study, 640 Japanese men were followed up for 5 years. The liver to spleen (L/S) ratio of the CT attenuation value was used as the liver fat accumulation index. We calculated the odds ratio (OR) and 95% confidence interval (CI) for the DM incidence of per 1 standard deviation (SD) lower L/S and those of L/S < 1.0 compared with L/S ≥ 1.0, using logistic regression models. RESULTS: Both per 1 SD lower L/S and L/S < 1.0 were significantly associated with a risk for DM incidence (1 SD lower L/S: OR = 1.57, 95%CI = 1.14-2.16; L/S < 1.0: OR = 2.27, 95%CI = 1.00-5.14). The relationship between L/S and incidence of DM was consistent in the obese and non-obese groups, with thresholds of BMI 25 kg/m2, waist circumference 85 cm, or visceral adipose tissue 100 cm2. CONCLUSIONS: Liver fat accumulation assessed by CT was associated with the incidence of DM.

Total energy expenditure is comparable between patients with and without diabetes mellitus: Clinical Evaluation of Energy Requirements in Patients with Diabetes Mellitus (CLEVER-DM) Study.

Objective: Assessment of total energy expenditure (TEE) is essential for appropriate recommendations regarding dietary intake and physical activity in patients with and without diabetes mellitus (DM). However, few reports have focused on TEE in patients with DM, particularly in Asian countries. Therefore, we evaluated TEE in Japanese patients with DM using the doubly labeled water (DLW) method and physical activity level (PAL). Research design and methods: In this cross-sectional observational study, we evaluated 52 patients with type 2 DM and 15 patients without DM. Free-living TEE was measured over 12-16 days by the DLW method, and PAL was calculated as TEE divided by the basal metabolic rate (BMR) as assessed by indirect calorimetry. The equivalence margin was defined as 5 kcal/kg/day. Results: The numbers of patients with DM treated with insulin, oral antidiabetic drugs, and diet were 18 (34.6%), 20 (38.5%), and 14 (26.9%), respectively. The mean±SD level of glycated hemoglobin was 6.9%±0.8% and 5.5%±0.3% in the DM and non-DM group, respectively (p<0.001). The mean body mass index was 23.3±3.0 and 22.7±2.1 kg/m2 in the DM and non-DM group, respectively. The mean TEE per kilogram body weight adjusted for sex and age was 36.5 kcal/kg/day and 37.5 kcal/kg/day in the DM and non-DM group, respectively, with no significant difference (mean difference, -1.0 kcal/kg/day; 95% CI -4.2 to 2.3 kcal/kg/day). The BMR tended to be higher in the DM than in the non-DM group (mean difference, 33 kcal/day; 95% CI, -15 to 80 kcal/day). The mean PAL adjusted for sex and age was 1.71 and 1.81 in the DM and non-DM group, respectively, without a significant difference (mean difference, -0.10; 95% CI -0.21 to 0.01). Conclusion: TEE was comparable between Japanese patients with and without DM. Trial registration number: UMIN000023051.

Ipragliflozin, a sodium-glucose cotransporter 2 inhibitor, reduces bodyweight and fat mass, but not muscle mass, in Japanese type 2 diabetes patients treated with insulin: A randomized clinical trial.

AIMS/INTRODUCTION: Sodium-glucose cotransporter 2 inhibitors reduce bodyweight (BW) by creating a negative energy balance. Previous reports have suggested that this BW reduction is mainly loss of body fat and that ~20% of the reduction is lean mass. However, the effects of sodium-glucose cotransporter 2 inhibitors on BW and body composition remain unclear. We examined these effects in Japanese patients with type 2 diabetes mellitus treated with insulin. MATERIALS AND METHODS: In this open-label, randomized controlled trial, 49 overweight patients (body mass index ≥23 kg/m2 ) with inadequate glycemic control (hemoglobin A1c >7.0%) receiving insulin treatment were randomly assigned to receive add-on ipragliflozin or no additional treatment (control group). Patients were followed for 24 weeks. The goal for all patients was to achieve glycated hemoglobin <7.0% without hypoglycemia. The primary end-point was a change in BW from baseline to week 24. Body composition was assessed with dual-energy X-ray absorptiometry and bioelectrical impedance analysis. RESULTS: BW change was significantly larger in the ipragliflozin group than in the control group (-2.78 vs -0.22 kg, P < 0.0001). Total fat mass was reduced evenly in the arms, lower limbs and trunk in the ipragliflozin group. Total muscle mass and bone mineral content were maintained, but muscle mass in the arms might have been affected by ipragliflozin treatment. CONCLUSIONS: Ipragliflozin treatment for 24 weeks resulted in reduced BW, mainly from fat mass loss. Muscle mass and bone mineral content were maintained. Further study is necessary to elucidate the long-term effects of ipragliflozin.

A case of local delayed-type allergy to zinc-containing insulin as a cause of diabetic ketoacidosis in a patient with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion.

We herein report a case involving a woman with type 1 diabetes and a history of metal allergy who developed a local delayed-type (type IV) allergy to zinc-containing insulin. She had been treated by continuous subcutaneous insulin infusion, but her glycemic control was poor, and she developed diabetic ketoacidosis. Her plasma insulin concentration was unexpectedly low during use of insulin lispro, but it was recovered by changing from the zinc-containing insulin lispro to the zinc-free insulin glulisine. Intradermal tests showed no reactions to various insulins except for zinc chloride. A skin biopsy at the injection site of insulin lispro showed invasion of lymphocytes, neutrophils, and eosinophils, but a skin biopsy at the injection site of insulin glulisine showed invasion of only lymphocytes. A drug lymphocyte stimulation test against polaprezinc, an antiulcer drug containing zinc, was positive. Therefore, we diagnosed the patient with local delayed allergy to zinc-containing insulin. Insulin allergy should be considered as a possible cause of poor glycemic control and diabetic ketoacidosis in patients with type 1 diabetes.